This study investigates the use of the patients own immune cells to treat prostate cancer. Cells are taken from the patient and grown in the laboratory to become specialized immune cells called dendritic cells. Dendritic cells instruct other immune cells to recognize and attack foreign substances such as bacteria, viruses, or abnormal proteins on cancer cells. A protein called Tn-MUC-1 is added to the cells.This protein is present on prostate cancer cells. The modified cells are injected back into the patient, with the intention that the dendritic cells will instruct other immune cells to attack the prostate cancer cells.

Time to radiographic progression [ Time Frame: Time to radiographic progression defined as the time from the first treatment to the occurence of any metastatic disease ] [ Designated as safety issue: No ]

Radiographic disease as measured by the occurence of any metastatic disease based on modified RECIST 1.0 and/or the appearance of 2 or more new lesions on a bone scan.

Secondary Outcome Measures:

Number of participants with adverse events [ Time Frame: Ongoing up to 2 years ] [ Designated as safety issue: Yes ]

Acute and late toxicities as assessed by NCI CTCAE v 4.0

Time to PSA progression [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]

Immune response [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]

Immune response defined as the induction of a cellular (CD4/CD8)response measured by CFSE or ICS assay and/or the induction of a humoral response as measured by an increase in specific antibody or the occurence of antibody isotype switching.

Overall survival [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]

Disease-specific survival [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]

Patients undergo one standard apheresis to harvest peripheral mononuclear cells for dendritic cell vaccine preparation. The modified cells (vaccine) are frozen so that multiple injections may be given. Patients my receive up to 5 injections. The vaccine is given either intradermally or into a lymph node.

Patients will undergo blood sample collection for immune response studies on the day of treatment and 2 weeks following treatment.

Eligibility

Ages Eligible for Study:

19 Years and older

Genders Eligible for Study:

Male

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Subject has a histologically documented diagnosis of prostate cancer

Subject was surgically castrated at least 3 months prior to study inclusion or has been pharmacologically castrated for a minimum of 3 months prior to study inclusion.

A 50% rise in PSA values with a minimum rise of 1.0 ng/ml (µg/L), within 6 months prior to study inclusion OR

A rise in PSA defined by 2 sequential increases in PSA values. inclusion. There must be at least 2 weeks between each qualifying PSA value.

Subjects who have received anti-androgen therapy must have a documented withdrawal period prior to study inclusion.

For a subject who has withdrawn from anti-androgen therapy LESS than 6 months prior to study inclusion, one of the following criteria is ALSO required for eligibility:

Following the completion of the anti-androgen withdrawal period, one post-withdrawal PSA value must be higher than the last pre-withdrawal PSA value OR

Following the completion of the anti-androgen withdrawal period, if the subject's PSA value decreased, then he can still qualify if two increases in PSA values (as described in 4c) are documented after post-withdrawal nadir.

At the time of screening the subject has no distant metastatic disease.

Exclusion Criteria:

Subject is less than 19 years of age.

Subject has a PSA value < 1.0 ng/mL at screening

Subject currently has evidence of distant metastases.

Subject has not, in the opinion of the investigator, a life expectancy greater than 12 months.

Subject has a local recurrence and is a candidate for local salvage therapy

Subject is on a concurrent steroids or immunosuppressive therapy for chronic inflammatory disease.

Subject has had other malignancies within the previous 5 years with the exception of non-melanoma skin cancer.

Subject has a score >1 on the ECOG Performance Scale (see Appendix I)

Subject has an inadequate hematologic function

Subject has inadequate liver function.

Subject has a creatinine clearance <40 mL/min

Subject has a known history of cardiovascular disability status of New York Heart Association Class ≥2.

Subject has a history of uncontrolled asthma

Subject has autoimmune disease(s)

Subject has active infection(s)

Subject is receiving antiretroviral therapy.

Subject has received blood transfusion within 8 weeks of study inclusion.

Subject has a clinically significant, unstable, uncontrolled disease that could be adversely affected by study participation.

Subject has known allergy to shellfish

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00852007